TX Q&A

If each individual module within the combination product is listed in the "Catalogue of Medical Devices Exempt from Clinical Evaluation," and the applicant can prove that there is no interaction between the modules, and that the clinical use does not exceed the scope of the catalogue, then the product can be considered a simple combination of multiple functional modules. Each module can then be evaluated separately according to the requirements of the catalogue. Additionally, the applicant should also assess any other risks that may arise from the combination of the modules.

The compatibility of the main unit, transducer, and cutting head in ultrasonic soft tissue cutting and hemostatic devices significantly affects the product's safety and efficacy. These components need to be designed and developed as a whole. Even if the use with products from other manufacturers that have already been approved for the market has been thoroughly verified and confirmed during the design and development phase, if changes in the design of the other party's products are not promptly understood, it is impossible to conduct a systematic analysis of these changes. This may lead to compatibility issues, introducing risks to safety and effectiveness. Therefore, unless there is a clear collaborative relationship between the registrants of the cutting head, main unit, and transducer, ensuring a systematic analysis of each other's product design changes, the use of the cutting head with main units and transducers from other manufacturers is not permitted.

When multiple receiving coils are used together in an MRI system, the registration documents should pay attention to the following issues: The overview should explain how the coils are combined during joint use, how the patient is positioned, and the corresponding areas scanned on the patient. The research documents should provide performance study data on signal-to-noise ratio, uniformity, 2D scan slice thickness, spatial resolution, ghosting, etc. In addition to the performance requirements for individual coils, the product technical requirements should also include the performance requirements when multiple coils are used together. The clinical evaluation data should assess the combined coils based on the applicable scanning areas.

For implantable cardioverter defibrillators and similar products that have already referenced the GB 16174.1 and YY 0989.6 standards in their product technical requirements, although implantable cardioverter defibrillators possess pacing functions, the YY 0989.6 standard has already adequately considered the pacing capabilities of these devices and made corresponding provisions. Therefore, there is no need to reference the GB 16174.2 standard.

For large imaging equipment (such as CT, MR, PET/CT, etc.), if a third-party physiological gating interface is provided (but not including the gating device), such as respiratory gating interface, ECG gating interface, etc., the overview materials should clearly specify the relevant requirements for compatible third-party gating devices, such as connection methods, interface/data types, etc. If it is a dedicated interface, the manufacturer and product model of the compatible devices should also be specified. The research materials should provide verification and validation documents for testing with third-party devices. The technical requirements should clearly specify the connection methods, interface/data types, and the technical indicators related to gating should be tested.

When describing computer configurations in the product technical requirements, such as CPU frequency, storage space, memory space, and monitor resolution, it is advisable to specify the minimum requirements. When upgrading computer configurations, verification of related design changes can be managed through the quality management system. If the upgrades do not involve changes to the product technical requirements, there is no need to register for a change in licensing matters.

If a new model of the high-voltage generator is added and the overall performance of the device remains substantially the same, it can, in principle, be declared as the same registration unit. The situation where the X-ray combined head of a dental cone-beam CT device adds a model can be handled in a similar manner.

The purpose of the analytical performance study of clinical projects for PCR detection equipment is to evaluate the overall performance of the equipment and reagents in representative clinical applications. The reagents used for evaluation should be mature and reliable. Generally, reagents that are already on the market should be used for the study. If there are no available reagents on the market, it is permissible to use reagents that are not yet marketed but have been finalized for the study.

For imaging products used in a vehicle-mounted environment (used when the vehicle is stationary), it is recommended to still use the standard name of the imaging product. The content "used in a vehicle-mounted environment" should be added to the expected use environment of the product. If it is used exclusively in a vehicle-mounted environment, this can be reflected in the scope of application.

To determine the sample size for dynamic testing of posterior spinal internal fixation systems, initially evaluate two samples under the initial fatigue load to establish the maximum fatigue load. Ensure that no sample damage occurs before 5,000,000 cycles. Subsequently, conduct fatigue tests on two samples each time until the difference between the load at structural failure and the maximum fatigue load is less than 10% of the compressive bending ultimate load. Plot a semi-logarithmic fatigue curve of compressive bending load versus the number of cycles to failure. Applicants should determine the sample size for dynamic testing based on the actual conditions of the product being registered. According to the "Guidance for Technical Review of Posterior Spinal Internal Fixation System Registration," the sample size for dynamic testing should not be less than 6 sets (individuals).